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Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. This early phase clinical study will evaluate the distribution of limonene to the breast tissue and its associated biological activities after 2 to 6 weeks of limonene dosing in women with a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials of developing limonene as a breast cancer preventive agent.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Women who are 18 years of age or older
Women electing to undergo excision surgery for early stage breast cancer
A minimum of 2 weeks from enrollment to definitive surgery
Underwent core needle biopsy for breast cancer diagnosis
No clinical evidence of metastatic breast cancer
ECOG performance status 0-1
Participants must have normal organ and marrow function
Women of child-bearing potential must agree to use adequate contraception
Ability to understand and the willingness to sign a written informed consent document
Concurrent chemotherapy or radiation therapy
Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
Participated in another clinical intervention trial within the past 3 months
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or breast-feeding women
Use of dietary supplement that contains large amounts of d-limonene (such as Heartburn Free with ROH10 and CoQ with d-limonene) within the past 3 months